HIC: Pilot Social Network Weight Loss Intervention

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT04273503
Collaborator
(none)
39
1
1
5.1
7.7

Study Details

Study Description

Brief Summary

Specific Aim #1: Pilot test a social network-informed CBPR-derived health promotion program for feasibility outcomes with overweight or obese adults from two immigrant communities.

Specific Aim #2: Assess the preliminary impact of embedding a social network-informed CBPR-derived intervention within a regional health promotion resource hub on sustainability and uptake outcomes.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mentoring/educational session
N/A

Detailed Description

The intervention will consist of 12 community-based mentoring and education sessions, group activities and application of a community toolkit for healthy weight loss delivered by trained interventionists from Hispanic and Somali communities to their social networks. Using a pre-post study design, 4 social networks of adults with approximately 32 network participants will receive the intervention. Primary outcomes, measured 3 months after implementation, will include feasibility measures of acceptability, implementation, and practicality. Secondary outcomes will include BMI, waist circumference, blood pressure, fasting blood glucose, total cholesterol, physical activity level, dietary change, and health-related quality of life.

Eligibility criteria include (1) self-identification as Hispanic or Somali, (2) member of an HPs social network, (3) age≥18 and <65 (4) willingness to participate in all aspects of the study; and (5) provision of informed consent. Exclusion criteria include (1) pregnancy at the time of enrollment and (2) serious medical conditions or disabilities that would make physical activity difficult.

We will test how best to integrate a social network intervention within an existing evidence-based regional health promotion infrastructure (WellConnect) that will enhance its potential dissemination and community-wide uptake

Study Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Behavioral interventionBehavioral intervention
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Healthy Immigrant Community: Pilot Social Network Weight Loss Intervention
Actual Study Start Date :
Jan 28, 2020
Actual Primary Completion Date :
Jun 26, 2020
Actual Study Completion Date :
Jun 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

All participants will receive education on maintaining a healthy diet and improving physical activity.

Behavioral: Mentoring/educational session
12 mentoring/educational sessions focused on physical activity and healthy nutrition by Mayo Clinic experts.

Outcome Measures

Primary Outcome Measures

  1. Acceptability [12 weeks]

    To what extent did was the intervention judged as relevant, satisfying, or helpful to HPs and participants? Interviews with HPs; focus groups and survey with participants.

Secondary Outcome Measures

  1. Weight [12 weeks]

    Weight will be measured to the nearest 0.1 kg using a portable scale (Seca 880 Digital Floor Scale). BMI is calculated as weight (kg)/height squared (m2).

  2. Waist circumference [12 weeks]

    Waist circumference will be measured to the nearest 0.1 cm at the narrowest part of the torso between the ribs and the iliac crest. Participants will remove all excess clothing prior to the measurement and smooth the remaining clothing against the skin. Two measurements will be taken; if the difference between the two measures is more than 2.0 cm, a third measurement will be taken. The average of the two closest measures will be used for analyses.

  3. Glucose [12 weeks]

    Collected by a single finger prick. Participants will be asked to refrain from eating for at least 6 hours prior to testing. Samples used for testing are whole blood from a fingerstick collected in a lithium heparin coated capillary tube.

  4. Cholesterol [12 weeks]

    Collected by a single finger prick. Participants will be asked to refrain from eating for at least 6 hours prior to testing. The portable Whole Blood Lipid Screen Cholestech LDX Analyzer will be used to analyze specimens, which combines enzymatic methodology and solid-phase technology measured by reflectance photometry to measure total cholesterol, HDL cholesterol, triglycerides and glucose in whole blood. LDL cholesterol is a calculated value. Samples used for testing are whole blood from a fingerstick collected in a lithium heparin coated capillary tube. Results will be recorded at the site of collection and samples will be destroyed upon recording of results.

  5. Height [12 weeks]

    Height will be measured to the nearest 0.1 cm at baseline only using a stadiometer.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. self-identification as Hispanic or Somali

  2. member of an HPs social network

  3. age≥18 and <65

  4. willingness to participate in all aspects of the study

  5. provision of informed consent.

Exclusion Criteria:
  1. pregnancy at the time of enrollment

  2. serious medical conditions or disabilities that would make physical activity difficult.

  • To avoid stigmatization, a normal weight (BMI<25) will not exclude individuals from participating, but they will be excluded from the measurements and analyses.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Mark Wieland, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Mark L Wieland, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04273503
Other Study ID Numbers:
  • 19-011574
First Posted:
Feb 18, 2020
Last Update Posted:
Jul 30, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 30, 2021